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Oesophageal atresia (EA) is a rare congenital anomaly whose prevalence varies between 1 and 2 per 5000 live births in Europe. This condition is characterised by an interruption of the oesophagus often associated with the presence of a tracheo-oesophageal fistula (FTE).
Although considerable progress has been made in the treatment of AE in recent years, the aetiology of this defect is still not fully understood and several theories have been put forward to explain this phenomenon. What they have in common is an abnormal separation of the primary oesophagus and trachea. The main goal of AE treatment is the closure of the FTE using surgical techniques.
This is a non-profit, multicentre longitudinal observational cohort study. This study will enrol patients who underwent surgery for oesophageal atresia during the period 2011-2021 and are still in follow-up at participating clinical centres.
The primary objective is to assess the incidence of musculoskeletal abnormalities, of any type, in the long term (4 years after surgery) in patients with oesophageal atresia treated surgically by two different approaches: postero-lateral thoracotomy and mini-thoracotomy with muscle preservation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with oesophageal atresia minithoracotomy | Patients with oesophageal atresia who underwent a minithoracotomy between 2011-2021 |
| |
| Patients with oesophageal atresia postero-lateral thoracotomy | Patients with oesophageal atresia who underwent a postero-lateral thoracotomy between 2011-2021 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postero-lateral thoracotomy | Procedure | this incision extends from the anterior axillary line, goes posteriorly behind the scapula and includes the division of the fibres of the latissimus dorsi muscle and the serratus anterior muscle. The latter approach presents the risk of numerous long-term musculoskeletal complications such as costal abnormalities (costal hypoplasia, costal fusion), winged scapula, scoliotic spine posture |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of musculoskeletal abnormalities patients with oesophageal atresia treated surgically | evaluate the incidence of musculoskeletal abnormalities, of all types, in the long term (4 years after surgery) in patients with oesophageal atresia treated surgically using two different approaches: postero-lateral thoracotomy and mini-thoracotomy with muscle preservation. | Four years after the beginning of the study |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of musculoskeletal abnormalities in the short term | assess the incidence of musculoskeletal abnormalities in the short term (6 months after surgery); | Six months after surgery |
| incidence of musculoskeletal abnormalities in the medium term |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with oesophageal atresia (type III according to Ladd's classification).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa Sieri | Contact | 055 5662900 | elisa.sieri@meyer.it |
| Name | Affiliation | Role |
|---|---|---|
| Elisa Severi | Meyer Children's Hospital IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spedali Civili di Brescia | Recruiting | Brescia | 25123 | Italy |
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| ID | Term |
|---|---|
| D004933 | Esophageal Atresia |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Minithoracotomy | Procedure | Minithoracotomy aims to preserve the muscles of the rib cage by retracting or disconnecting them rather than sectioning them (muscle sparing technique) |
|
to assess the incidence of musculo-skeletal abnormalities in the medium term (24 months after surgery);
| Twentyfour months after surgery |
| Evaluation of severity of outcomes in the medium, short and long term | evaluate the severity of outcomes (musculoskeletal abnormalities, respiratory pathologies, eating disorders) in the medium, short and long term. Musculoskeletal abnormalities will be evaluated using the "Trunk Aesthetic Clinical Evaluation (TRACE) Scale"; this scale involves evaluation of shoulder asimmetry (1-3), scapulae asimmetry (1-2), hemi-thorax asimmetry (1-2), waist asimmetry (1-4). Respiratory pathologies are defined as the presence or absence of asthma and recurrent respiratory infections that requires hospitalization (>3 per years). Eating disorders will be defined on the base of the consistence and the dimension of the pieces of food eaten by the child. | One year after the Beginning of the study |
| Predective Facotrs evaluation | evaluate the effect of potential predictive factors (such as incision type, intercostal space opening, pleural approach) on abnormalities at different time-points. Musculoskeletal abnormalities will be evaluated using the "Trunk Aesthetic Clinical Evaluation (TRACE) Scale"; this scale involves evaluation of shoulder asimmetry (1-3), scapulae asimmetry (1-2), hemi-thorax asimmetry (1-2), waist asimmetry (1-4). | One year after the Beginning of the study |
| Meyer Children's Hospital IRCCS | Recruiting | Florence | 50139 | Italy |
|
| Ospedale Bambino Gesù di Roma | Recruiting | Roma | 00165 | Italy |
|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |